Status:
UNKNOWN
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
Lead Sponsor:
Seoul St. Mary's Hospital
Conditions:
Diabetes Complications
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy. Design: Prospective interventional case series. Participants: ...
Eligibility Criteria
Inclusion
- patients of either gender aged \> 18 years
- patients with type 2 diabetes
- central macular thickness \> 300 µm on OCT
- eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (\< 500 µm)
- an area of retinal thickening less than 2 disc areas in diameter
- 67% or more of leakage associated with microaneurysms
Exclusion
- eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
- eyes with any pharmacologic intervention on fellow eye within 6 months
- history of ocular diseases other than diabetic retinopathy
- surgical history other than cataract extraction with intraocular lens implantation
- panretinal photocoagulation within 3 months of enrollment
- media opacity
- any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01422018
Start Date
August 1 2011
End Date
February 1 2012
Last Update
September 23 2011
Active Locations (1)
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1
Seoul St Mary's hospital
Seocho, Seoul, South Korea, 137-070